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510(k) Data Aggregation

    K Number
    K040195
    Device Name
    CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM
    Manufacturer
    WITT BIOMEDICAL CORP
    Date Cleared
    2004-04-07

    (70 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CALYSTO Image IV is an image and information management system intended for image data acquisition, archival, distribution, viewing and analysis for medical images of all modalities as well as Electrocardiogram (ECG) images. It's users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Image IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

    The CALYSTO ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format. and made available for review and procedural report generation purposes. CALYSTO ECG Management System does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users. responsible to interpret the data made available, will be professional health care providers. CALYSTO ECG Management System provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet, or may function as a stand-alone device.

    Device Description

    CALYSTO Image IV is an image and information management system. The CALYSTO ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving the device meets said criteria for the "CALYSTO Image IV - Image and Information Management System."

    The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the device's indications for use and regulatory classification, but it does not detail any performance studies, acceptance criteria, or specific metrics about the device's performance. Therefore, I cannot generate the requested table and study information.

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